Applied statistics for scientists and engineers

Applied statistics for scientists and engineers is necessary for a number of reasons. 21 CFR and guidance documents for the pharmaceutical, biopharmaceutical, and medical device industries specify the application of statistical methods for these functions:

o  Setting validation criteria and specifications

o  Performing Measurement Systems Analysis (MSA)

o  Conducting stability analysis

o  Using Design of Experiment (DOE) for process development and validation

o  Developing process control charts, and

o  Determining process capability indices.

Since scientists and engineers are at the heart of these functions, they need to have a thorough knowledge of how to use applied statistics. Each of these particular applications requires different and specified statistical methods. The common tools used for setting acceptance criteria and specifications are data and tolerance intervals, while for setting expiries and conducting stability analysis studies; simple linear regression and analysis-of-covariance (ANCOVA) are used.

For analyzing designed experiment for process development and validation studies, two-sample hypothesis tests, analysis-of-variance (ANOVA), regression, and ANCOVA are methods used, while for developing process control charts and developing process capability indices; descriptive statistics (distribution, summary statistics), run charts, and probability (distributions) are used.

Explaining the importance of applied statistics for scientists and engineers

A seminar that is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance, will explain the importance of applied statistics for scientists and engineers.

In the course of making the importance of applied statistics for scientists and engineers known; the Director at this seminar, Heath Rushing, who is the cofounder of Adsurgo and author of the book Design and Analysis of Experiments by Douglas Montgomery: A Supplement for using JMP, and has been an invited speaker on applicability of statistics for national and international conferences, will provide instruction on applied statistics for scientists and engineers and statistical methods for data analysis of applications related to the pharmaceutical, biopharmaceutical, and medical device industries.

To enroll for this highly valuable and practical course on applied statistics for scientists and engineers, just register by visiting http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900790?wordpress_SEO .

The course “Applied Statistics for Scientists and Engineers” has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

The tools that help an understanding of applied statistics for scientists and engineers

This course on applied statistics for scientists and engineers will offer thorough instruction on how scientists and engineers need to apply the appropriate statistical approaches: descriptive statistics, data intervals, hypothesis testing, ANOVA, regression, ANCOVA, and model building. The Director will present the ways of establishing competence in each of these areas and industry-specific applications.

The application of statistical methods across the product quality lifecycle is specified in the 21 CFR and guidance documents for the pharmaceutical, biopharmaceutical, and medical device industries. There are many statistical methods that may be applied to satisfy this portion of the QSR. Yet, some commonly accepted methods can and should be used by all companies to:

o  Develop acceptance criteria

o  Ensure accurate and precise measurement systems

o  Fully characterize manufacturing processes

o  Monitor and control process results and

o  To select an appropriate number of samples.

At this seminar on applied statistics for scientists and engineers, Rushing will provide instruction on all these. He will cover the following areas over the two days of this seminar:

o  Describe and analyze the distribution of data

o  Develop summary statistics

o  Generate and analyze statistical intervals and hypothesis tests to make data-driven decisions

o  Describe the relationship between and among two or more factors or responses

o  Understand issues related to sampling and calculate appropriate sample sizes

o  Use statistical intervals to setting specifications/develop acceptance criteria

o  Use Measurement Systems Analysis (MSA) to estimate variance associated with: repeatability, intermediate precision, and reproducibility

o  Ensure your process is in (statistical) control and capable

Statistics for the Non-Statistician: Is it necessary?

Statistics for the non-statistician: Isn’t this some kind of a contradiction in terms? Why does a non-statistician need to rake his head over statistics? Is statistics a life skill or a lifesaving one? If it is not, why is statistics for the non-statistician necessary? At first glance, statistics for the non-statistician may appear unnecessary and redundant, but a slightly deeper look will make one understand that statistics for the non-statistician is indeed important, and has uses that help to make important contributions to the organization in which they work.

For understanding processes

Statistics for the non-statistician is important because we need statistics in the course of our professions while taking important decisions in business. For those working in the corporate world, statistics for the non-statistician becomes an important tool and skill with which a deeper understanding can be made of the statistical tools and techniques that employees routinely use in an organization. Using these tools, the professional has a greater understanding of the important parameters and pointers of the business and how to bring about improvements in the quality of a firm’s process and product.

Why statistics is important for the non-statistician can also be understood from the fact that when statistics is not properly analyzed, i.e., when statistical analysis is not performed insightfully as a result of a lack of full understanding of the statistical principles and processes by the employees; the organization faces a number of problems. These range from the possibility of facing the risk of producing a poor quality product. Such a product severely retards its ability to deliver a high quality product, as a result of which there is a heavy negative impact on the organization’s bottom line, as well as a blow to its reputation.

Get to understand the importance of statistics for the non-statistician

The importance of statistics for the non-statistician can also be understood from the fact that its knowledge helps regulatory professionals meet regulatory compliance requirements without hassles. To get a clear understanding of the ways in which statistics for the non-statistician helps organizations overcome many challenges, a seminar is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance.

At this seminar on statistics for the non-statistician, Steven Walfish, the founder and President of Statistical Outsourcing Services, who brings nearly 20 years of industrial experience providing statistical solutions to complex business problems, will be the Director. To enroll for this seminar, please visit http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900742SEMINAR?linkedin_SEO. The “Statistics for the Non-Statistician” has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

It is all about practice

Practice is at the root of understanding statistics for the non-statistician. Constant practice is the mantra for employees to attain proficiency in statistics. They need a little bit of initiative, familiarity and some real-world example data sets. Employees who need training on statistics for the non-statistician need an understanding of the most common statistical tools and terms.

They need to understand

a.      how to use statistics to properly trend data

b.     support the annual product review

c.      justify process changes

d.     set product specifications.

The aspects of statistics that employees need to be familiar with

Employees who want to learn how statistics works for the non-statistician need to be able to make use of statistical software packages and understand the role of software in statistical analysis and statistical process control. They also need to have the skills necessary to design a statistically sound sampling plan that helps them comply with FDA APR requirements.

The result of this kind of familiarization is that organizations can perform their core functions and still be in alignment with statistical processes that are necessary for staying ahead of the competition. This is what statistics for the non-statistician entails.

The course on statistics for the non-statistician is immensely useful to professionals and supervisors in medical devices, diagnostics, pharmaceuticals and the biologics fields.

Globalcompliancepanel Successfully Completed Seminar in Philadelphia-Design of Experiments and Statistical Process

Design of Experiments and Statistical Process Control for Process Development and Validation

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Getting Design of Experiments and Statistical Process Control right for Process Development and Validation

Procedures must be used in the application of DOE and SPC to the development, design and monitoring of manufacturing and testing processes. Why this needs to be done is because the FDA has, in a recent guidance document on Process Validation, assigned the responsibility for reviewing and interpreting DOE and SPC studies to the Quality Unit.

fda-round

Going about doing this work requires a practical orientation. It calls for an approach with case studies and examples. A seminar that is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, will provide just this and fulfill this requirement.

Dr. Steven Kuwahara, Founder and Principal, GXP BioTechnology LLC, will be the Director at this two-day session. To enroll for this valuable session, please register by logging on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900701SEMINAR. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

An interactive session

Dr. Kuwahara will offer theoretical information introduced only when necessary to understand an experiment. A highly interactive and practical session; this seminar offers examples from real processes and testing procedures and present the participants with examples that will be directly applicable to their work.

For any pharmaceutical worker who performs, supervises or reviews manufacturing or testing processes, an understanding of the relationships among the process parameters and the ability to monitor the performance of processes and test methods are necessary. This is all the truer of the worker in Quality Control and Quality Assurance in view of the recent FDA guidance document on Process Validation.

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This work, however, is done by the development, manufacturing, or quality systems worker. So, synchrony between these two levels of employees is needed. This course will equip these two levels of employees with the knowledge of how to design the systems and studies, and interpret the results generated.

Applied Statistics for product and process evaluation in design and manufacturing

Evaluating product and processes is an imperative for almost all design and/or manufacturing companies. These are the reasons for which this evaluation needs to be made:

  • Managing risks
  • Validation of processes
  • Establishing product/process specifications to QC to such specifications
  • Monitoring compliance to such specifications

risk

Lack of proper and thorough grasp of and correct implementation of statistical methods leads a company to having to face significant increases in its complaint rates, scrap rates, and time-to-market. As a result, such companies churn out poor quality in their products, leading to lowered customer satisfaction levels, severely impacting their bottom line.

A learning session to help understand statistical methods

In order to help professionals in process and manufacturing meet challenges associated with statistical methods with greater confidence, GlobalCompliancePanel, a highly reputable provider of professional trainings for the regulatory compliance areas, is organizing a highly educative two-day seminar on the topic, “Applied Statistics, with Emphasis on Verification, Validation, and Risk Management, in R&D, Manufacturing, and QA/QC”.

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John N. Zorich, Statistical Consultant & Trainer, Ohlone College & SV Polytechnic, will be the Director at this seminar, which has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

To enroll for this seminar, participants can log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900537SEMINAR.

Hands on approach to statistical methods toolbox

The aim of this seminar is to offer a hands-on approach by which the participants could comprehend the ways to interpret and use a standard tool-box of statistical methods that consist of confidence intervals, t-tests, Normal K-tables, Normality tests, confidence/reliability calculations, AQL sampling plans, measurement equipment analysis, and Statistical Process Control.

The Director will equip the seminar delegates with clarity on how to accurately employ and administer statistical methods, which can be used as a launchpad for introducing new products.

medical-device

This two-day session will help participants understand the proper way of avoiding issues relating to these aspects of statistical methods. John will explain how to apply statistics to manage risk in R&D, QA/QC, and Manufacturing by giving real life examples derived mainly from the medical device design/manufacturing industry.

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John will cover the following areas at this seminar:

  • FDA, ISO 9001/13485, and MDD requirements related to statistical methods
  • How to apply statistical methods to manage product-related risks to patient, doctor, and the designing/manufacturing company
  • Design Control processes (verification, validation, risk management, design input)
  • QA/QC processes (sampling plans, monitoring of validated processes, setting of QC specifications, evaluation of measurement equipment)
  • Manufacturing processes (process validation, equipment qualification).

New Way of Exploring Economic Environment

Lineament analysis in geological exploration

The existence of efficient and cost-effective methods that help to identify prospective targets that are related to or are influenced by tectonic structures is not common knowledge among professionals in the field of geological exploration.

The right sampling and Quality Assurance/Quality Control (QA/QC) procedures are essential in all aspects of the mineral deposit evaluation process to achieve the best possible confidence in resultant mineral resource and reserve estimates.

Getting Quality Assurance and Quality Control procedures and protocols right is crucial

Accurate and proper QA and QC procedures and protocols are essential to ensure that data collected and created by the mining organization is of a high level of quality and is in compliance with CIM Standards and Guidelines. Geological quality control procedures are meant to monitor precision and accuracy of the assay data, as well as possible sample contamination during sample preparation and assaying. The quality of the data used determines the quality of an estimate.

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To offer a complete understanding of this concept, GlobalCompliancePanel, a reputable provider of professional trainings for all areas of regulatory compliance, will be organizing a two-day, live seminar. Please visit http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900719SEMINAR?new-economic-environment-Boston-MA.

The Director of this seminar, Ricardo Valls, will introduce to the participants a methodology that will help them to concentrate their exploration efforts even over new areas with limited or nonexistent geological information, while keeping their budget in check.

The centrality of QA&QC procedures

Ricardo will explain how lineament and satellite interpretation are a way to define where to concentrate exploration efforts, as well as how to implement QA&QC procedures to guarantee the quality of the collected data. This is necessary, considering that compliance with the industry-established QA/QC is no longer an option, but a necessity for all the companies to implement, especially those that trade in the markets. Quality assurance is essentially the management system that operates to ensure credible results. The prime objective of the field QA program is to maximize accuracy by reducing introduced variability.

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The learning will be gleaned from a quality assurance program that the Director has implemented for the field sampling procedures. This includes collection, labeling, and shipping components. The quality control component of this system is a set of activities intended to control the quality of the data from collection through to analysis. It consists of day-to-day activities such as:

  • The adherence to written protocols; up-to-date and suitable training of personnel
  • The use of reliable laboratories with excellent QA&QC systems in place
  • The regular use of quality control (QC) samples (blanks, standard samples, and field duplicates)
  • Diligent record keeping.

Ricardo will cover the following areas at this seminar:

  • History of the problem, why we need to change the current approach
  • Lineament analysis
  • Lineament analysis and satellite interpretation of data
  • Physical modeling (3D strain analysis and 3D stress analysis)
  • Statistical procedures (Compositional data analysis, correlation analysis, principal component and other methods)
  • Defining a QA/QC program, Blanks, duplicates, standards, external controls
  • Procedures and audits
  • Rock naming in the field
  • Conclusions and recommendations.

Applied Statistics for product and process evaluation in design and manufacturing

Evaluating product and processes is an imperative for almost all design and/or manufacturing companies. These are the reasons for which this evaluation needs to be made:

  • Managing risks
  • Validation of processes
  • Establishing product/process specifications to QC to such specifications
  • Monitoring compliance to such specifications

Lack of proper and thorough grasp of and correct implementation of statistical methods leads a company to having to face significant increases in its complaint rates, scrap rates, and time-to-market. As a result, such companies churn out poor quality in their products, leading to lowered customer satisfaction levels, severely impacting their bottom line.

appliedstats

A learning session to help understand statistical methods

In order to help professionals in process and manufacturing meet challenges associated with statistical methods with greater confidence, GlobalCompliancePanel, a highly reputable provider of professional trainings for the regulatory compliance areas, is organizing a highly educative two-day seminar on the topic, “Applied Statistics, with Emphasis on Verification, Validation, and Risk Management, in R&D, Manufacturing, and QA/QC”.

John N. Zorich, Statistical Consultant & Trainer, Ohlone College & SV Polytechnic, will be the Director at this seminar, which has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

To enroll for this seminar, participants can log on to

http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900535SEMINAR?applied-statistics-QA-QC-Seattle-Washington.

Hands on approach to statistical methods toolbox

The aim of this seminar is to offer a hands-on approach by which the participants could comprehend the ways to interpret and use a standard tool-box of statistical methods that consist of confidence intervals, t-tests, Normal K-tables, Normality tests, confidence/reliability calculations, AQL sampling plans, measurement equipment analysis, and Statistical Process Control.

The Director will equip the seminar delegates with clarity on how to accurately employ and administer statistical methods, which can be used as a launchpad for introducing new products.

This two-day session will help participants understand the proper way of avoiding issues relating to these aspects of statistical methods. John will explain how to apply statistics to manage risk in R&D, QA/QC, and Manufacturing by giving real life examples derived mainly from the medical device design/manufacturing industry.